Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives
The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) when used as food additives. Benzoic acid and its sodium and potassium salts are rapidly absorbed after oral administration. The Panel considered that the absorption, distribution, metabolism and excretion of calcium benzoate will be similar to sodium or potassium salt and, therefore, read-across between the salts was possible. The results of short-term and subchronic studies on benzoic acid and its salts indicate that their toxicity is low. The Panel considered that the use of benzoic acid and its sodium and potassium salts as food additives does not raise a concern with respect to genotoxicity and, based on read-across, also considered that this conclusion is applicable for calcium benzoate. Moreover, the Panel noted that the available data did not indicate any carcinogenic potential. A four-generation reproductive toxicity study with benzoic acid in the diet in rats was considered by the Panel as the pivotal study and a no observed adverse effect level of 500 mg benzoic acid/kg body weight (bw) per day, the highest dose tested, was identified. From the aforementioned studies, the Panel derived an acceptable daily intake (ADI) of 5 mg/kg bw per day (expressed as benzoic acid) using an uncertainty factor of 100. Taking into account food categories for which direct addition of benzoic acid-benzoates is authorised, the group ADI was exceeded in the brand-loyal scenario in particular for toddlers and children consuming on a regular basis flavoured drinks. Considering additional exposure due to carry-over, the intake could be increased by up to two to three fold for all high-level consumers compared to the previous scenario with only direct addition to food. This results in exceedance of the group ADI in toddlers and children for the non-brand-loyal scenario. The main food categories contributing to this exceedance were unprocessed fruits and vegetables and flavoured drinks.